Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm

The primary objective is to demonstrate that a higher proportion of responders to deep brain stimulation (DBS) in the anterior nucleus (AN) of the thalamus in refractory epilepsy patients in the SANTE study exhibit a recruitment rhythm relative to non-responders.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Enrolled in the SANTÉ study, have been implanted with a complete DBS system, and is currently receiving stimulation in the long-term follow-up phase (post Month 13) of the study
Patient or legal representative is able to understand and provide signed consent for participating in the study
Willing and available to attend the visit as scheduled and to comply with the study protocol

Exclusion criteria

Patients unable to tolerate stimulation turned OFF during the testing period
Are pregnant or suspected of being pregnant

Treatment and study plan

There was no intervention.

Device

There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.

Primary outcomes

To demonstrate that a higher proportion of DBS responders exhibit a RR relative to non-responders, using maximum tolerated voltage settings, at activated electrode contacts used for DBS stimulation in the SANTE study.

Time frame: Study testing to occur during the long-term follow-up phase of the SANTE trial.

Secondary outcomes

For patients without a RR at their activated DBS electrode contacts used in the SANTE study, demonstrate that activating other electrode contacts generates a RR.

Time frame: Study testing to occur during the long-term follow-up phase of the SANTE trial.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm (SANTE RR)

Acronym: SANTE RR

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Oct 15, 2008
Registry last updated: Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed